Scrub-stat Solution
FDA Label NDC 47593-463

13 label sections · Submitted to the FDA by Ecolab Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ecolab Inc. for the product Scrub-stat (NDC 47593-463). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Chlorhexidine gluconate solution, 2%

Purpose

Surgical hand scrub

Healthcare personnel handwash

Uses

  • surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • healthcare personnel handwash: handwash to help reduce bacteria that potentially can cause disease

Warnings

For external use only

Allergy alert:

This product may cause a severe allergic reaction.

Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

    • if an allergic reaction occurs, stop use and seek medical help right away.

Do Not Use

  • if you are allergic to chlorhexidine gluconate or any other ingredients in this product

When Using This Product

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated ear drums.
  • if contact occurs, rinse with cold water right away
  • do not use routinely if you have wounds which involve more than the superficial layers of the skin 

Stop Use And Ask A Doctor If

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • use full strength
  • do not dilute

    • Surgical hand scrub

    • remove jewelry
    • wet hands and forearms with water and dispense 6 pumps (5 mL) of the product onto hands
    • wash/scrub hands and forearms for 3 minutes paying particular attention to the nails, cuticles, and interdigital spaces
    • rinse thoroughly with water
    • wash for an additional 3 minutes with 6 pumps (5 mL) of the product into hands and rinse under running water
    • dry thoroughly

      • Healthcare personnel handwash

      • wet hands with water
      • dispense 6 pumps (5 mL) of product into hands and wash in a vigorous manner for 30 seconds
      • rinse and dry thoroughly

Other Information

  • store between 20-25°C (68-77°F)
  • avoid excessive heat (above 104°F/40°C)
  • for additional information, see Safety Data Sheet (SDS)
  • for emergency medical information in USA and Canada, call 1.800.328.0026
  • for emergency medical information worldwide, call 1.651.222.5352 (in the USA)

Inactive Ingredient

Inactive ingredients cocamide DEA, cocamine oxide, fragrance, gluconic acid*, gluconolactone*, hydroxyehtylcellulose, isopropyl alcohol 4%, PEG-75 lanolin, PEG-150 distearate, propylene glycol, quaternium-60, water

*contains one or more of these ingredients

Otc - Questions

Questions? call 1.866.781.8787, 24 hours a day, 7 days a week.

Representative Label And Principal Display Panel

ECOLAB®

NDC 47596-463-41

SCRUB-STAT 2%

Chorhexidine Gluconate 2% Solution Antiseptic

Surgical Hand Scrub and

Healthcare Personnel Handwash

6000068

Net Content:

25 fl oz (750 mL)

KEEP FROM FREEZING

Ecolab • 1 Ecolab Place • St Paul MN 55102 USA

© 2020 Ecolab USA Inc • All rights reserved

Made in United States

www.ecolab.com • 762356/8502/1220

Representative Label (Label)

Representative Label (Label)

* Please review the disclaimer below.